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Targeting HIV Retention and Improved Viral Load Through Engagement ('THRIVE')

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04481373
Recruitment Status : Enrolling by invitation
First Posted : July 22, 2020
Last Update Posted : March 31, 2023
Sponsor:
Collaborators:
University of Iowa
Brown University
University of Texas
Information provided by (Responsible Party):
Thomas Giordano, Baylor College of Medicine

Study Description
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Brief Summary:
Many people with HIV infection are not consistently engaged in outpatient HIV care, and avoidance, stigma and denial contribute to poor engagement in HIV care. This project will develop and pilot test a new intervention, "THRIVE," for hospitalized persons who are out of HIV care and endorse avoidance, to improve how well they stay in outpatient HIV care after discharge. If successfully developed, the intervention will undergo large scale testing in later studies and could improve the health of persons with HIV infection and help end the HIV epidemic in the United States.

Condition or disease Intervention/treatment Phase
Human Immunodeficiency Virus Depression Anxiety Behavioral: THRIVE Other: Treatment as Usual Not Applicable

Detailed Description:
Poor retention in HIV primary care results in lower rates of HIV viral suppression, higher rates of HIV transmission, and exacerbates racial and ethnic disparities in health outcomes, including survival. To date, there are no interventions that effectively relink and retain PWH in care when they are found outside the HIV clinic. Many persons with HIV infection (PWH) are hospitalized with life-threatening but preventable complications of inadequately treated HIV infection. They are among the most important patients to retain in care. Our previous research shows that among PWH who are out of care and hospitalized, avoidance coping, stigma, and mental health difficulties were nearly universal. Further, avoidance coping was a predictor of failure to re-engage in care after discharge. Acceptance and Commitment Therapy (ACT) is a transdiagnostic intervention with the capacity to address a range of psychosocial and behavior-related issues that PWH experience. ACT helps patients overcome avoidance, particularly avoidance of uncomfortable internal states and the situations that trigger such states, by promoting acceptance-based coping and re-engagement in meaningful and valued-life activities. Brief ACT interventions appear to be feasible, acceptable, and at least preliminarily, have efficacy. The investigators propose to develop, refine, and pilot a brief (4-5 contact hours) ACT intervention for hospitalized, out-of-care PWH. 'Targeting HIV Retention and Improved Viral load through Engagement' ('THRIVE') will aim to help patients overcome avoidance, a maladaptive coping strategy implicated in a range of problems, including depression, anxiety, substance abuse, and HIV-related self-stigma, all of which constitute barriers to care. Delivering THRIVE in the hospital with a phone booster session after discharge will increase therapy initiation and completion, the lack of which is often the greatest obstacle to effective delivery of mental health services for PWH. In Aim 1, a brief hospital-based transdiagnostic, individually delivered ACT intervention (THRIVE) tailored specifically for out-of-care hospitalized PWH will be developed. Input from a multi-disciplinary team of expert care providers and PHW will be utilized to create the therapist protocol and patient workbook. The investigators will then pilot THRIVE in 10 hospitalized out-of-care PWH who will provide qualitative feedback on the intervention. The feedback, along with input from patients and the multi-disciplinary team, will be used to refine THRIVE. In Aim 2, the investigators will conduct a pilot randomized clinical trial (RCT) of the refined THRIVE intervention (N=35) compared to treatment as usual (N=35). This pilot RCT will 1) evaluate feasibility and acceptability for a full-scale RCT; and 2) examine trends in outcomes of interest for the definitive RCT. The investigators will then be positioned to submit a separate grant to test the efficacy of THRIVE in a fully powered randomized trial. This work has the potential to decrease HIV morbidity and racial/ethnic disparities and contribute to ending the HIV epidemic in the United States, which are NIH priorities.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Targeting HIV Retention and Improved Viral Load Through Engagement ('THRIVE')
Actual Study Start Date : March 3, 2021
Estimated Primary Completion Date : December 31, 2023
Estimated Study Completion Date : December 31, 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

Arms and Interventions
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Arm Intervention/treatment
Experimental: THRIVE
Acceptance and Commitment Therapy plus Education about HIV A master's level mental health professional will provide the 4-5 hour intervention for out-of-care PWH during a hospitalization. There are two important components to the intervention: Acceptance and Commitment Therapy (ACT) content, targeting avoidance with acceptance-based coping and active engagement in values-based living, and HIV education.
 Behavioral: THRIVE

The ACT components (3-3.5 hours) will focus on clarifying patient values and goals and identifying obstacles that may be getting in the way of living a rich life. Short-and long-term effects of avoidance will be discussed (e.g., avoidance reduces immediate contact with distressing experiences and provides short-term relief but leads to greater dysfunction in long run). Patients will be taught acceptance, mindfulness, and perspective taking to help patient cope with difficult emotions and thoughts that may interfere with living a values-driven life. Individuals will also be encouraged to examine the costs of stigmatization on their life (e.g. avoidance of medical care, sense of isolation).

Education will include medical information about HIV, services available at the clinic, and health needs related to comorbidities. This content to be delivered in 30 minutes.

Other Name: Acceptance and Commitment Therapy plus Education
Treatment as Usual
Patients get usual care at the hospital. Service linkage workers (SLWs) meet with all hospitalized PWH and cover educational aspects of the care.
 Other: Treatment as Usual
Patients get usual care at the hospital. Service linkage workers (SLWs) meet with all hospitalized PWH and cover educational aspects of the care.


Outcome Measures
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Primary Outcome Measures :
  1. Acceptability of enrollment and randomization [ Time Frame: 6 months ]
    The number of eligible PWH who agree and decline to participate, and reasons for declining;

  2. Acceptability of enrollment and randomization [ Time Frame: 6 months ]
    The number of PWH who are not eligible to participate and the reasons for lack of eligibility.

  3. Acceptability of the intervention [ Time Frame: 6 months ]
    Intervention completion rate

  4. Acceptability of the intervention [ Time Frame: 6 months ]
    Retention of participants in follow-up assessments

  5. Acceptability of the intervention [ Time Frame: 6 months ]
    Duration of contacts


Secondary Outcome Measures :
  1. Viral Load Improvement [ Time Frame: 6 months ]
    Change in Viral Load

  2. Number of patients who are retained in HIV Care [ Time Frame: 6 months ]
    Number of patients who complete at least 2 visits with an HIV clinician within 6 months


Other Outcome Measures:
  1. Internalized AIDS-Related Stigma Scale (IARSS) [ Time Frame: 6 months ]
    This is a 6-item measure examines internalized stigma. Response scores range from 0 (low stigma)-6 (high stigma) with higher scores representing higher levels of stigma.

  2. Depression Anxiety and Stress Scale (DASS-21). [ Time Frame: 6 months ]
    This is a 21-item measure. The total score ranges from 0-120 with higher scores reflecting higher levels of distress including depression, anxiety, and stress.

  3. Alcohol Use Disorders Identification Test (AUDIT) [ Time Frame: 6 months ]
    This 3-item screener that identifies problem alcohol use for both men and women. Participants respond on a 5-point scale. Higher numbers represent more difficulty.

  4. The Alcohol, Smoking and Substance Involvement Screening Test (ASSIST) [ Time Frame: 6 months ]
    This measure asks about substance use of 7 categories of drugs in the previous 3 months and in a person's life time. Participants respond YES or NO to each category of drugs.

  5. Coping with HIV/AIDS scale [ Time Frame: 6 months ]
    This is a 16 item measure that examines positive coping, avoidant coping, and social support. Items are scores from 1-3 with higher scores reflecting greater positive coping, greater avoidant coping, and greater social support.

  6. Client Satisfaction Questionnaire (CSQ) [ Time Frame: 6 months ]
    This 8-item measure assesses patient satisfaction with services. Scores range from 8-32 with higher scores representing greater satisfaction.


Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Hospitalized at Ben Taub Hospital, Houston, TX;
  • at least 18 years of age;
  • able to speak English or Spanish;
  • HIV infected;
  • able to provide informed consent and participate in the study (patients who are temporarily unable to participate will be followed and approached for enrollment if and when they are cognitively and physically capable of consenting and participating);
  • HIV VL>1000 c/mL;
  • never in care or currently out of HIV care, defined as not meeting the 'visit constancy' measure (≥1 completed HIV primary care visit at Thomas Street Health Center (TSHC), Houston, TX, in each of the three 4-month intervals preceding admission); or ≥2 "no shows" to HIV primary care visits at TSHC in the last year.
  • endorse one of two avoidance coping statements with the highest factor loadings on the Avoidant Coping Subscale from the Coping with HIV/AIDS scale

Exclusion Criteria:

  • intending to use a source of HIV primary care other than TSHC after discharge, because their outcomes cannot be evaluated;
  • in the opinion of the primary medical team caring for the patient, likely to be discharged to an institutional setting, die in the hospital or enter hospice;
  • incarcerated or expected to be discharged to prison or jail;
  • enrolled in another research study with prospective follow-up;
  • pregnant, since pregnant women receive additional efforts to be linked and retained in care;
  • admitted with acute psychosis which would preclude informed consent or meaningful participation with the intervention.
Contacts and Locations
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Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04481373


Locations
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United States, Texas
Ben Taub Hospital
Houston, Texas, United States, 77030
Sponsors and Collaborators
Baylor College of Medicine
University of Iowa
Brown University
University of Texas
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Thomas Giordano, Professor, Baylor College of Medicine
ClinicalTrials.gov Identifier: NCT04481373    
Other Study ID Numbers: H-47444
First Posted: July 22, 2020    Key Record Dates
Last Update Posted: March 31, 2023
Last Verified: March 2023

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Thomas Giordano, Baylor College of Medicine:
Acceptance and Commitment Therapy
HIV
depression
 anxiety
distress
avoidance
Additional relevant MeSH terms:
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Acquired Immunodeficiency Syndrome
HIV Infections
Depression
Behavioral Symptoms
Immunologic Deficiency Syndromes
Immune System Diseases
Blood-Borne Infections
Communicable Diseases
Infections
 Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Slow Virus Diseases
Genital Diseases
Urogenital Diseases